Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

Not Applicable

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Behavioral: Dialectical behavior therapy (DBT)

• Registration Number: NCT01952405
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.

Detailed Description

This study will be a 3-year randomized control trial. Patients will be referred from any mental health services in Taipei area who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder. Inclusion criteria include subjects who fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder, 18-60 years of age, sign the informed consent, have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the 3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I disorder, severe physical illness, and mental retardation. Outcome measures will be obtained at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol. Using semi-structured interview and a battery of self-report forms, a range of symptoms and behaviors associated with Borderline Personality Disorder will be assessed including suicidal thought, suicide attempt, depression, hopelessness, quality of life, disability, service utilization, and function. Measures are selected based on previous outcome studies of dialectical behavior therapy. Outcome variables will be evaluated by blinded assessors.

Study Timeline

• Study Start: 2013-05-18
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-09-30
• Primary Completion: 2017-02-24
• Study Completion: 2017-02-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• meeting DSM-IV criteria for borderline personality disorder
• 18-60 years of age
• have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years,
• at least one episode of suicidal is in the 3 months preceding enrollment
• agreement to participate in evaluation of the program.

Exclusion Criteria

• bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days
• living outside of Taipei area
• having any serious medical condition likely to require hospitalization within the next year (e.g. cancer)
• and having plans to leave the Taipei area in the next 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialectical behavior therapy	Dialectical behavior therapy (DBT)	Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.
alternative psychotherapy	Dialectical behavior therapy (DBT)	The therapists of the alternative psychotherapy in the comparison group are asked to provide the type and dose of therapy that they believed is most suited to the patient, with a minimum of 1 scheduled individual session per week. Ancillary treatment could be prescribed as needed. Case management strategies are also available in the comparison group (alternative psychotherapy group). No restrictions are placed on ancillary pharmacotherapy in either condition.

Primary Outcome Measures

Name	Time	Method
Suicide Attempt Self-Injury Interview (SASII)	4 months, 8 months and 12 months	change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Beck Hopelessness Scale (BHS)	4 months, 8 months and 12months
Brief Disability Questionnaire (BDQ)	4 months, 8 months and 12 months
Borderline Personality Disorder Subscale	4 months, 8 months and 12 months	Borderline Personality Disorder Subscale (Chinese version) of the Structured Clinical Interview for DSM-IV axis II Personality Disorders ((SCID-II)
Borderline Symptom Checklist (BSL-23)	4 months, 8 months and 12 months
The Patient Health Questionnaire (PHQ-9)	4 months, 8 months and 12 months
Symptom Checklist-90-Revised (SCL-90-R)	4 months , 8 months and 12 months
Beck Scale for Suicide Ideation (BSSI)	4 months , 8months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)	4 months, 8 months and 12 months
Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)	4 months, 8 months and 12 months
Treatment History Interview (THI)	4 months, 8 months and 12 months

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan